Single Arm, Single Center Phase IV Clinical Trial to Evaluate the Immune Persistence and Safety of Freeze-dried Human Rabies Vaccine (Vero Cell)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- positive conversion rate evaluation (6 months)
研究概览
简要总结
Evaluation of immune persistence after rabies vaccination in 150 people.
详细描述
150 subjects aged 10-60 were recruited to inoculate the frozen human rabies vaccine (Vero cells) produced and marketed by Changchun Zhuoyi Biological Co., Ltd. in the whole process of 0, 3, 7, 14 and 28 day immunization. The immunogenicity persistence and safety of the test vaccine were evaluated 14 days, 6 months and 12 months after the whole process of vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •10-60 years old；
- •Temperature on the day of admission≤37.0 ° C (axillary temperature).
排除标准
- •Have a history of rabies vaccine immunization or use of rabies virus passive immunization agents；
- •Has been diagnosed with congenital or acquired immunodeficiency disease;
- •Pregnancy (including positive urine pregnancy test) or lactation, planned pregnancy preparation within 2 months.
结局指标
主要结局
positive conversion rate evaluation (6 months)
时间窗: 6 months
Evaluate the positive conversion rate 6 months after vaccination of rabies vaccine according to the 5-dose immunization program
antibody titer evaluation (6 months)
时间窗: 6 months
Evaluate the antibody titer of serum neutralizing antibody 6 months after vaccination of rabies vaccine according to the 5-dose immunization program
positive conversion rate evaluation (12 months)
时间窗: 12 months
Evaluate the positive conversion rate 12 months after vaccination of rabies vaccine according to the 5-dose immunization program
antibody titer evaluation (12 months)
时间窗: 12 months
Evaluate the antibody titer of serum neutralizing antibody 12 months after vaccination of rabies vaccine according to the 5-dose immunization program
次要结局
未报告次要终点